MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) had a strong resistance inside the microcatheter.Dr.Had no choice but to pull out the coil (subject device) in the microcatheter and discovered that the coil (subject device) is prematurely detached prior to its release from hypotube.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the coil (subject device) had a strong resistance inside the microcatheter.Dr.Had no choice but to pull out the coil (subject device) in the microcatheter and discovered that the coil (subject device) is prematurely detached prior to its release from hypotube.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During a visual inspection, the coil proximal contact was seen to be kinked, there was a slight kink in the delivery wire, the main coil was seen to be detached, the main coil was not returned, and the introducer sheath was seen to be intact.A functional inspection was not available.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The reported main coil prematurely detached/separated during use was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.Continues flush was maintained throughout the procedure.Additional information provide was the customer, there was strong resistance inside the microcatheter, wile the physician removed the coil from the microcatheter it was discovered the coil was already detached.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' and 'main coil prematurely detached/separated during use' these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil proximal contact kinked/bent' and 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during preparation.As the defects are associated with out of box failure.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil prematurely detached/separated during use' these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17687728
• Report Number: 3008881809-2023-00450
• Device Sequence Number: 6512722
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2025
• Device Catalogue Number: M0035421030
• Device Lot Number: 24059554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Sex: Male